Farmeconomia. Health economics and therapeutic pathways
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A pharmacoeconomic analysis of the use of single MMC instillation in low risk NMIBC in Italy
Full text linkBACKGROUND: Bladder cancer accounts for 5-10% of all cancers in Europe and up to 85% patients presents a noninvasive tumor, whose treatment of choice is the transurethral bladder resection (TURB) paired with adjuvant intravesical chemotherapy or immunotherapy. Despite several clinical trials showed that this treatment is safe and decreases recurrences by 17% to 44% this practice is limited for many reasons. The study objective is to analyze the economical advantages of the single immediate post operative Mitomycin C instillation in Non Muscle-invasive Bladder Cancer (NMIBC) low-risk patients.METHODS: A cost-benefit analysis was performed evaluating the economical gain that would raised from a scenario with a single immediate post operative mitomycin C instillation in each low-risk NMIBC patient who underwent to TURB. Net present value and cost-benefit ratio were calculated and sensitivity analyses were performed. Base case analysis was performed considering tumor recurrence rate reduction of 11.7% and a TURB costs of 2,167.0 €, while sensitivity analyses were performed using a recurrence rate reduction of 19.2% and 15.0% and a TURB cost of 2,472.93 €. The discount rate was 2%.RESULTS: The single immediate post operative instillation of mitomycin C resulted to be cost-beneficial with a cost-benefit ratio that goes from 0.48 to 0.79 when compared to TURB alone raising a Net Present Value that goes from 660,284.39 € to 2,650,530.79 €.CONCLUSION: This study demonstrates that even assuming conservative parameters for recurrence rates reduction, a single immediate post operative mitomycin C instillation in low risk NMIBC patients would lower not only the recurrence rate but also the caring cost for bladder cancer
Costs of treatment of haemophilia A in Italy: comparison of the use of plasma-derived and recombinant FVIII using a discrete event simulation (DES) model
Full text linkOBJECTIVE: To simulate haemophilia A (HA) real-life management and compare the cost of different treatment strategies, both with plasma-derived and recombinant factor VIII (pdFVIII and rFVIII, respectively), from the perspective of the Italian NHS.METHODS: A discrete event (micro-)simulation (DES) model was developed to reproduce every possible HA patient clinical pathway: on-demand (OD) treatment of bleeding, continuous or discontinuous prophylaxis (PRO) with FVIII, inhibitors-tolerance-induction treatment (ITI), surgery in case of severe disability. Patient characteristics, treatment indications and disease evolution were modeled basing on data available in clinical literature in order to represent the actual state of art of HA management. In addition to the baseline scenario, reproducing current HA management, alternative strategies were simulated to explore the impact on the cost borne by the Italian NHS for these patients. Only differential direct sanitary costs were considered in the simulation, with a 3.5% discount rate.RESULTS: Baseline scenario results show difference between patients treated with pdFVIII and those treated with rFVIII: mean lifetime HA patient management cost was estimated at € 1,332,373 with pdFVIII treatment, compared with € 2,013,222 for rFVIII. The saving is due mainly to the lower acquisition cost of pdFVIII. Total medical costs are strongly and positively correlated with HA severity: cost per patient increases from € 86,269 (mild HA) to € 1,509,231 (severe HA) for patients treated with pdFVIII and from € 147,900 to € 2,621,540 in patients treated with rFVIII. All analyses conducted in the study lead to the conclusion that the use of pdFVIII is much less expensive than rFVIII, but therapeutically equivalent.CONCLUSION: Management of HA patients is complex and difficult to optimize; although involving a limited number of patients, lifetime management costs for the Italian NHS are extremely high. The main advantage of this model lies in the capability of estimating the economic impact of different strategic choices and economic/regulatory constraints
The utility of a model-based cost-effectiveness analysis of degarelix versus leuprolide in the therapy of hormone-dependent advanced prostate cancer
Full text linkINTRODUCTION: Prostate cancer (PC) is a very common tumor among men: in Italy its prevalence in 2006 was 0.9%. Androgen deprivation therapy is a way to treat hormone-responsive PC by decreasing testosterone levels. GnRH-analogues, including GnRH-agonists and GnRH-antagonists, are effective for this purpose. AIM: This article presents a cost-effectiveness analysis based on a semi-Markov model comparing the GnRH-antagonist degarelix and GnRH-agonist leuprolide in the treatment of hormone-dependent advanced prostate cancer from the perspective of the Regional Health Service in Veneto Region (Italy).MATERIALS AND METHODS: Effectiveness data were retrieved by a 12-month phase III non-inferiority clinical trial, comparing degarelix and 7,5 mg leuprolide in 610 patients treated for hormone-dependent prostate cancer. Epidemiological data came from a national database and were referred to Veneto Region. The values of the healthcare resources were calculated using regional and national prices (€ 2012). The model considers 3 exhaustive and mutually exclusive health status: first-line treatment, further-lines treatment and death. It lasts 10 years, with 28 days per cycle. The entry in the model is hypothesized at the age of 70 (the age with most PCs in Veneto Region). Effectiveness endpoints were life years saved and quality-adjusted life years, using 3% social discount rate. The incremental cost per QALY was related to the range of acceptability proposed by the Associazione Italiana di Economia Sanitaria (€ 25,000-40,000). The budget impact was calculated on a 5-year time horizon. Univariate and probabilistic sensitivity analyses were performed on every hypothesis of the model.RESULTS: Degarelix resulted in minor costs if compared to 7.5 mg leuprolide (€ 20,511.64 vs 22,256.49). The cost-driver was chemotherapic care (32.45% degarelix vs 44.30% 7.5 mg leuprolide). Life years saved were the same for both the alternatives (5.58), while QALYs obtained were higher in degarelix vs. 7.5 mg leuprolide (4.41 vs. 4.10). QALY better data probably could results from greater delay to disease progression in castrate resistant phase with degarelix than comparator and also due to superior symptoms relief. Therefore degarelix is dominant compared to the agonist. The probability for degarelix to be cost-effective increases with the increasing of the threshold for incremental QALY, being 69.95%, 93.76%, 95.55%, and 97.42% for threshold values equal to € 0, € 25,000, € 40,000, and € 100,000, respectively. The use of degarelix in Veneto Region instead of 7.5 mg leuprolide would result, after a five-year period, in total savings for the Regional Health Service equal to € 4,783, considering the treatment of 259 patients.CONCLUSIONS: In the treatment of hormone-dependent advanced prostate cancer PC, degarelix is thought to be an economically rational investment of resources for the Regional Health Service of Veneto Region because it’s dominant, in term of cost-effectiveness, to the comparator (agonist) thanks to superior QALY and reduced costs
Valutazione di efficienza nella somministrazione dell’ormone della crescita (GH)
Full text linkTreatment with growth hormone (somatropin) is effective in six different medical conditions: growth hormone deficiency (GHD), Turner syndrome (TS), growth retardation in children born small for gestational age (SGA), Prader-Willi syndrome (PWS), growth retardation due to chronic renal insufficiency (CRI), growth retardation associated with a deficiency of the gene SHOX (Short Stature HOmeoboXContaining gene). The treatment proved to be also effective in adults who have an impaired growth hormone (acquired in adulthood or childhood).The growth hormone (GH) is generally cost effective and, therefore, is usually reimbursed by public health services. In financial terms, GH is a major cost item for health systems. According to the Report OSMED 2010, GH ranks first in Italy between systemic hormonal preparations, excluding sex hormones, distributed by public system, with an annual value of approximately € 88 million (+ 12.7% compared to 2009).Considering the increasing need to control pharmaceutical expenditure, there is a strong interest for the efficient supply of the hormone by the regional health service. From this point of view, the comparison of the specialties on the market is normally carried out on the basis of the cost per mg; this approach, also used in the main studies of cost-effectiveness, is derived from a logic of cost minimization, but it may still be distorting, not taking into account the efficiency of devices used for the administration of the hormone.The proposed analysis verifies the efficiency of different available devices, evaluating the potential waste of product, depending both on the device used and on the characteristics of the population exposed to the treatment.Only in the case of single-dose and disposable formulations is theoretically possible to have zero waste and thus an equivalence between the actual cost of the treatment and the price charged. In other cases, the inefficiency causes a deviation between the actual cost and price. In the latter cases, since the theoretical amount of the population exposed to the treatment, it is estimated that the total share of potentially unused product can vary between 208,000 mg / year to 750,000 mg / year, depending on the device used. In particular, there is an actual average cost of treatment ranging between +9.9% and +11.4% of the ex-factory price; depending on the different doses and even between the different devices, the difference between the actual price and the theoretical price varies from a minimum of +6.9% and a maximum of +18.7%
The use of dexmedetomidine in intensive care sedation
No full textThe goals and recommendations for ICU (Intensive Care Unit) patients’ sedation and analgesia should be to have adequately sedated patients who are calm and arousal, so that they can guarantee a proper evaluation and an adequate control of pain. This way, it is also possible to perform their neurological evaluation, preserving intellectual faculties and helping them in actively participating to their care. Dexmedetomidine is a selective alpha-2 receptor agonist, member of theraputical cathegory: “other hypnotics and sedatives” (ATC: N05CM18). Dexmedetomidine is recommended for the sedation of adult ICU patients who need a sedation level not deeper than arousal in response to verbal stimulation (corresponding to Richmond Agitation-Sedation Scale 0 to -3). After the EMA approval, some European government authorities have elaborated HTA on dexmedetomidine, based on clinical evidence derived from Prodex and Midex trials. Dexmedetomidine resulted to be as effective as propofol and midazolam in maintaining the target depth of sedation in ICU patients. The mean duration of mechanical ventilation with dexmedetomidine was numerically shorter than with propofol and significantly shorter than with midazolam. The resulting favourable economic profile of dexmedetomidine supported the clinical use in ICU. Dexmedetomidine seems to provide clinical benefits due to the reduction of mechanical ventilation and ventilator weaning duration. Within the present review, an economic analysis of costs associated to the use of dexmedetomidine was therefore performed also in the Italian care setting. Thus, four different analyses were carried out based on the quantification of the total number of days in ICU, the time spent on mechanical ventilation, the weighted average number of days with mechanical ventilation or not and TISS points (Therapeutic Intervention Scoring System). Despite the incremental cost for drug therapy associated with dexmedetomidine, a reduction of the management costs for ICU has been estimated, with savings ranging between € 800 and € 1,400 per patient.
Impact of dose rounding of cancer therapy on cost avoidance: a pilot study
Full text linkBACKGROUND: A significant and progressive cost rising in medical oncology due to the incorporation of novel and highly expensive drugs into clinical practice have been seen in the past ten years. Dose rounding is an option might be used in oncology settings to avoid extra cost. The purpose of this project is to determine the theoretical cost saving related to a dose rounding process for biological and chemotherapy agents in adult oncology settings and to determine the opinion of oncologists about dose rounding.MATERIALS AND METHODS: Data was obtained prospectively during April 2011. All chemotherapy and targeted therapy orders prescribed in adult oncology outpatient clinics as well as in-patient wards have been collected. We considered rounding to an amount within 15% for targeted therapy and 10% for cytotoxic drugs. Chemotherapy dosing was calculated according to body surface area. Prescriptions that include cancer therapy in doses that might be rounded according to study criteria were identified.RESULTS: Two hundred and thirty three orders of chemotherapy and targeted therapy were processed by Adult Oncology Satellite Pharmacy during the period of data collection. Forty percent of the collected prescriptions fulfilled the criteria. The potential cost savings from dose rounding per year was 80,820 (42%), followed by colorectal cancer 45,107 (23%) and for other types of cancer that include non small cell lung cancer, prostate and ovarian cancer, in addition to head and neck cost savings was $18,867 (10%).CONCLUSIONS: Our experience confirms the significant cost savings of cancer therapy by applying dose rounding to chemotherapy and biologic drugs prescriptions. While clinical impact of the suggested percentage needs to be evaluated
Results of reference pricing and reimbursement discount rate schemes of Turkey
Full text linkOBJECTIVES: General Directorate of Pharmaceuticals and Pharmacy (IEGM) is responsible for setting all prices for human medicinal products. The reference pricing system is used for setting these prices. Reference countries are reviewed annually and may be subject to certain alterations. There were 5 reference countries in 2009: Spain, Italy, Germany, France and Greece. The aim of this study is to show the distribution of reference countries which were used for reference pricing.METHODS: The price list of pharmaceuticals which was published by IEGM on 15.04.2011 was used for analysis. Distribution of reference countries and prices were evaluated.RESULTS: Prices of 6,251 generic and 3,703 original products were set according to the price list. 5,283 of generics and 3,306 of originals were in the positive list for reimbursement. Reference pricing was used for 2,352 generics and 2,281 originals. Prices of the remaining were set outside of reference pricing. 32 different countries were used for reference pricing. Italy was the most popular country for reference pricing. Even if it was not a reference country, Germany was used in some of the pharmaceuticals. The average reimbursement discount rate and price were 24.43% and 249 TL, respectively. There were no colerations between price and reimbursement discount rate, or reference country and reimbursement rate.CONCLUSION: It has been shown that Italy has the highest impact on the pricing of all pharmaceuticals in Turkey. Even if it was not a reference country, Germany showed to affect pharmaceuticals more than other countries which were also not used for reference pricing. Even if reimbursement discount rates are stated by the Social Security Institution (SGK), there are different discount rates for pharmaceuticals. The analysis stated that there were correlation between price, country and discount rates. This analysis is first for the literature. Further analysis is necessary in the light of price changes and newly launched pharmaceuticals
European and Italian regulation on orphan medicinal products
Full text linkThe paper presents an overview of the European and Italian Regulation on Orphan Medicinal Products (OMPs), along with some data on the OMPs licensed in the EU from 2000 to 2012. The EU legislation encourages pharmaceutical companies to develop drugs for rare diseases, so-called “orphan drugs”. The European Medicine Agency recognizes orphan drug status mainly on the basis of the prevalence of the disease (≤ 5/10,000), and potential benefit. Orphan status implies incentives for pharmaceutical companies. From 2000 up to 2012 890 candidate orphan drug designations received a positive opinion and the marketing authorization was granted to 72 OMPs corresponding to 80 different indications. Currently, 59 OMPs are available to Italian patients either because licensed to the market by the AIFA or included in the list of the L. 648/96. Despite of an encouraging regulation nearly all the currently estimated rare diseases still await treatments